Utilizing Blood Volume Measurements in the Treatment of Heart Failure Patients (TEAM UF)

Christiana Care Health Services

Status: Completed

Conditions: Congestive Heart Failure

Treatments: Other: Ultrafiltration; Other: Ultrafiltration using BVM

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00861770

CCC28158

Details and patient eligibility

About

This will be a clinical test to determine if using blood volume measurements (BVM) to help guide fluid removal with ultrafiltration in patients hospitalized with decompensated heart failure leads to improved outcomes.

Full description

Subjects will be randomized into two groups. In the control group, the treating physician will not see the blood volume measurement results. In the experimental group, the physician will be given the blood volume measurement results. Ultrafiltration is performed based on the results of blood volume measurement in the experimental group followed by repeat blood volume analysis after 30 minutes of the completion of ultrafiltration. Clinical and laboratory assessment as per the standard of care will be used to assess overall fluid status, and blood volume measurement results will be used as the assessment of intravascular fluid. These assessments will be used to determine a goal quantity of fluid to be removed. All subjects will return for a clinical assessment at 30 and 90 days and laboratory data will be drawn at that time to evaluate renal functional indices, electrolytes and blood volume measurements.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Primary diagnosis of heart failure

• >/= 2 criteria of volume overload

  1. JVD > 7 cm
  2. Ascites
  3. Lower extremity edema
  4. Sacral Edema
  5. Pleural effusion by clinical or radiologic criteria

• CKD 3 or worse renal function ClCR < 60 ml/min

• HCT < 40%

• Serum Albumin >/= 2.5 gm/dL

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

1 - Control

Other group

Description:

All subjects will receive blood volume measurement immediately before and 30 minutes after ultrafiltration is completed. In the control group, the treating physician will not see the blood volume measurement results and treat according to standard of care.

Treatment:

Other: Ultrafiltration

2 - BVM

Experimental group

Description:

Ultrafiltration will be guided by blood volume measurement results.

Treatment:

Other: Ultrafiltration using BVM